Antiphospholipid SyndromeNCT00180817
Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.
An observational study of Antiphospholipid Syndrome, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Antiphospholipid Syndrome
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 1998to 31 Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Antiphospholipid syndrome History of recurrent miscarriages
Who cannot join
- Previous thromboembolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies in Women Presenting as Recurrent Miscarriages.
This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.
Read the detailed description
The association between APA and thrombosis is well documented. Both LA and ACA are often detected in individuals with SLE but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with APA. This study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (PAPS) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Antiphospholipid syndrome
- Medical subject headings
- Antiphospholipid Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 1998
- Primary completion31 Aug 2005
- Study completion31 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lesley Regan, Principal investigator, Imperial College LondonRaj Rai, MRCOG, Principal investigator, Imperial College LondonWinnie Lo, Principal investigator, St. Mary's NHS Trust, LondonPreeti Jindal, MRCOG, Principal investigator, St. Mary's NHS Trust, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180817
- Sponsor's protocol ID
- EC3103
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2005
- Last updated
- 8 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies in Women Presenting as Recurrent Miscarriages.
- ClinicalTrials.gov ID
- NCT00180817
- Acronym / sponsor ID
- EC3103
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Antiphospholipid syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Sep 1998 (actual)
- Primary completion
- 31 Aug 2005 (actual)
- Study completion
- 31 Aug 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.
Detailed description
The association between APA and thrombosis is well documented. Both LA and ACA are often detected in individuals with SLE but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with APA. This study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (PAPS) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.
Study design
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Antiphospholipid syndrome History of recurrent miscarriages
Key exclusion criteria (1 listed)
- Previous thromboembolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Related trials for Antiphospholipid Syndrome
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Follow-up Cohort of Patients With Antiphospholipid Syndrome
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MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
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RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Regan principal investigator
Imperial College London
Raj Rai, MRCOG principal investigator
Imperial College London
Winnie Lo principal investigator
St. Mary's NHS Trust, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.